Annex 21. Item 6.10. – Model Articles X.X.5. and X.X.6. for disease-specific chapters

Model Articles X.X.5. and X.X.6. for disease-specific chapters

**USA COMMENTS IN RED FONT**

CHAPTER X.X.

INFECTION WITH [PATHOGEN X]

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Article X.X.5.

Country free from infection with [Pathogen X]

As described in Article 1.4.~~4~~., a Member Country may make a self-declaration of freedom from infection with [Pathogen X] for its entire *territory* if it can demonstrate that:

1)	none of the *susceptible species* referred to in Article X.X.2. are present and *basic biosecurity conditions* have been continuously met for at least the last [~~six~~twelve] months;

**RATIONALE:**This timeframe should be amended to every 12 months, which would allow for a full cycle of seasons during which disease could present, as well as time for the Competent Authority to continually verify that there are no susceptible species present. Verifying that no susceptible species are present is easier at the compartment level (due to the smaller footprint), and this process is much more intensive at the country level so we should allow sufficient time to confidently determine the absence of susceptible species. Lastly, there is not a comparable requirement for 6 months on the Terrestrial side.

OR

2)	there has been no occurrence of infection with [Pathogen X] for at least the last [ten] years, and:

a)	the Member Country can demonstrate that conditions are conducive to the clinical expression of infection with [Pathogen X], as described in the corresponding chapter of the *Aquatic Manual*; and 

b)	*basic biosecurity conditions*as described in Chapter 1.4. have been continuously met for at least the last [ten] years; 

OR

3)	*targeted surveillance*, as described in Chapter 1.4., has been in place for at least the last [two] years without detection of [Pathogen X], and *basic biosecurity conditions* have been continuously met and have been in placefor at least [one] year prior to commencement of *targeted surveillance*;

OR

4)	it previously made a self-declaration of freedom from infection with [Pathogen X] and subsequently lost its free status due to the detection of [Pathogen X] but the following conditions have been met:

a)	on detection of [Pathogen X], the affected area was declared an *infected zone* and a *protection zone* was established; and

b)	infected populations within the *infected zone* have been killed and disposed of by means that minimise the likelihood of further transmission of [Pathogen X], and the appropriate *disinfection* procedures (as described in Chapter 4.4.) have been completed followed by fallowing as described in Chapter 4.7.; and

c)	previously existing *basic biosecurity conditions* have been reviewed and modified as necessary and have continuously been in place since eradication of infection with [Pathogen X]; and

d)	*targeted surveillance*, as described in Chapter 1.4., has been in place for:

i)	at least the last [two] years in wild and farmed *susceptible species*without detection of [Pathogen X]; or

ii)	If the goal is to demonstrate freedom in the farmed component, then at least the last [one] year without detection of [Pathogen X] if affected *aquaculture establishments* were not epidemiologically connected to wild populations of *susceptible species*.

**RATIONALE:**Edits****clarify that the intent of this statement is to decrease the timeframe for farmed populations. This text/option should appear in the "zone" section below as well.

In the meantime, the part of the country outside the *infected zone* and *protection zone*~~part or all of the country, apart from the *infected*and *protection zones,*~~ may be declared a *free**zone*as described in Article 1.4.4.~~provided that such a part meets the conditions in point 2 of Article X.X.6.~~

Article X.X.6.

Zone free from infection with [Pathogen X]

If a *zone* extends over the *territory* of more than one country, it can only be declared a *zone* free from infection with [Pathogen X] if all of the relevant *Competent Authorities* confirm that all relevant conditions have been met.

As described in Article 1.4.4., a Member Country may make a self-declaration of freedom from infection with [Pathogen X] for a *zone* within its *territory* if it can demonstrate that:

1)	none of the *susceptible species* referred to in Article X.X.2. are present and *basic biosecurity conditions* have been continuously met for at least the last [~~six~~twelve] months;

**RATIONALE:**This timeframe should be amended to every 12 months, which would allow for a full cycle of seasons during which disease could present, as well as time for the Competent Authority to continually verify that there are no susceptible species present. Verifying that no susceptible species are present is easier at the compartment level (due to the smaller footprint), and this process is much more intensive at the country level so we should allow sufficient time to confidently determine the absence of susceptible species. Lastly, there is not a comparable requirement for 6 months on the Terrestrial side.

OR

2)	there has been no occurrence of infection with [Pathogen X] for at least the last [ten] years, and:

a)	the Member Country can demonstrate that conditions are conducive to the clinical expression of infection with [Pathogen X], as described in Article 1.4.8. of Chapter 1.4.; and 

b)	*basic biosecurity conditions*as described in Chapter 1.4. have been continuously met for the *zone* for at least the last [ten] years;

OR

3)	*targeted surveillance*, as described in Chapter 1.4., has been in place in the *zone* for at least the last [two] years without detection of [Pathogen X], and *basic biosecurity conditions* have been continuously met and have been in place for at least [one] year prior to commencement of *targeted surveillance*; 

OR

4)	it previously made a self-declaration of freedom for a *zone* from infection with [Pathogen X] and subsequently lost its free status due to the detection of [Pathogen X] in the *zone* but the following conditions have been met:

a)	on detection of [Pathogen X], the affected area was declared an *infected zone* and a *protection zone* was established; and

b)	infected populations within the *infected zone* have been killed and disposed of by means that minimise the likelihood of further transmission of [Pathogen X], and the appropriate *disinfection* procedures (as described in Chapter 4.4.) have been completed followed by fallowing as described in Chapter 4.7.; and

c)	previously existing *basic biosecurity conditions* have been reviewed and modified as necessary and have continuously been in place since eradication of infection with [Pathogen X]; and

d)	*~~targeted surveillance~~*~~, as described in Chapter 1.4., has been in place for at least the last [two] years without detection of [Pathogen X].~~*targeted surveillance*, as described in Chapter 1.4., has been in place for:

i)at least the last [two] years in wild and farmed *susceptible species*without detection of [Pathogen X]; or

ii)If the goal is to demonstrate freedom in the farmed component, then at least the last [one] year without detection of [Pathogen X] if affected *aquaculture establishments* were not epidemiologically connected to wild populations of *susceptible species*.

**RATIONALE:**This section should mirror the country-level freedom section above. Edits clarify that the intent of this statement is to decrease the timeframe for farmed populations.  

In the meantime, a part of the *zone* outside the *infected zone*and *protection zone* may be declared a new *free zone* as described in Article 1.4.4.

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